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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01854775




Registration number
NCT01854775
Ethics application status
Date submitted
3/05/2013
Date registered
16/05/2013
Date last updated
16/10/2024

Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Scientific title
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Secondary ID [1] 0 0
2013-002780-26
Secondary ID [2] 0 0
GS-US-292-0106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Immune Deficiency Syndrome (AIDS) 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E/C/F/TAF
Treatment: Drugs - E/C/F/TAF (Low Dose)

Experimental: Cohort 1: Age 12 to < 18 Years and Weight = 35 kg - HIV-infected, ARV treatment-naive adolescents (12 to \< 18 years of age weighing = 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Experimental: Cohort 2: Age 6 to < 12 Years and Weight = 25 kg - Virologically suppressed HIV-infected children (6 to \< 12 years of age weighing = 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Experimental: Cohort 3: Age =2 Years and Weight = 14 to <25 kg - Virologically suppressed HIV-infected children (= 2 years of age weighing = 14 to \< 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of = 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.


Treatment: Drugs: E/C/F/TAF
Tablets administered orally with food.

Treatment: Drugs: E/C/F/TAF (Low Dose)
90/90/120/6 mg STR administered once daily orally with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)
Timepoint [1] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Primary outcome [2] 0 0
PK Parameter: AUCtau of EVG (Cohort 2)
Timepoint [2] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Primary outcome [3] 0 0
PK Parameter: AUCtau of EVG (Cohort 3)
Timepoint [3] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Primary outcome [4] 0 0
PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)
Timepoint [4] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Primary outcome [5] 0 0
PK Parameter: AUClast of TAF (Cohort 2)
Timepoint [5] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Primary outcome [6] 0 0
PK Parameter: AUCtau of TAF (Cohort 3)
Timepoint [6] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Primary outcome [7] 0 0
Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [7] 0 0
From first dose date up to Week 24
Primary outcome [8] 0 0
Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Timepoint [8] 0 0
From first dose date up to Week 24
Primary outcome [9] 0 0
Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs
Timepoint [9] 0 0
From first dose date up to Week 24
Secondary outcome [1] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)
Timepoint [1] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary outcome [2] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)
Timepoint [2] 0 0
(pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary outcome [3] 0 0
PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)
Timepoint [3] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary outcome [4] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)
Timepoint [4] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary outcome [5] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)
Timepoint [5] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary outcome [6] 0 0
PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)
Timepoint [6] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary outcome [7] 0 0
PK Parameter: CL of EVG and TAF (Cohort 1)
Timepoint [7] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary outcome [8] 0 0
PK Parameter: CL of EVG and TAF (Cohort 2)
Timepoint [8] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary outcome [9] 0 0
PK Parameter: CL of EVG and TAF (Cohort 3)
Timepoint [9] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary outcome [10] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 1)
Timepoint [10] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary outcome [11] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 2)
Timepoint [11] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary outcome [12] 0 0
PK Parameter: Vz of EVG and TAF (Cohort 3)
Timepoint [12] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary outcome [13] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)
Timepoint [13] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4
Secondary outcome [14] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)
Timepoint [14] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4
Secondary outcome [15] 0 0
PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)
Timepoint [15] 0 0
0 (pre-dose, = 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2
Secondary outcome [16] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [16] 0 0
Week 24
Secondary outcome [17] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [17] 0 0
Week 48
Secondary outcome [18] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [18] 0 0
Week 24
Secondary outcome [19] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [19] 0 0
Week 48
Secondary outcome [20] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [21] 0 0
Week 48
Secondary outcome [22] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis
Timepoint [22] 0 0
Week 24
Secondary outcome [23] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis
Timepoint [23] 0 0
Week 48
Secondary outcome [24] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [24] 0 0
Week 24
Secondary outcome [25] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [25] 0 0
Week 48
Secondary outcome [26] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [26] 0 0
Week 24
Secondary outcome [27] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [27] 0 0
Week 48
Secondary outcome [28] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [28] 0 0
Week 24
Secondary outcome [29] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [29] 0 0
Week 24
Secondary outcome [30] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [30] 0 0
Week 24
Secondary outcome [31] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [31] 0 0
Week 48
Secondary outcome [32] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses
Timepoint [32] 0 0
Week 24
Secondary outcome [33] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses
Timepoint [33] 0 0
Week 48
Secondary outcome [34] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [34] 0 0
Week 24
Secondary outcome [35] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [35] 0 0
Week 48
Secondary outcome [36] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [36] 0 0
Week 24
Secondary outcome [37] 0 0
Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [37] 0 0
Week 48
Secondary outcome [38] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [38] 0 0
Week 24
Secondary outcome [39] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [39] 0 0
Week 48
Secondary outcome [40] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [40] 0 0
Week 24
Secondary outcome [41] 0 0
Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [41] 0 0
Week 48
Secondary outcome [42] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses
Timepoint [42] 0 0
Week 24
Secondary outcome [43] 0 0
Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses
Timepoint [43] 0 0
Week 48
Secondary outcome [44] 0 0
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24
Timepoint [44] 0 0
Baseline, Week 24
Secondary outcome [45] 0 0
Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48
Timepoint [45] 0 0
Baseline, Week 48
Secondary outcome [46] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [46] 0 0
Baseline, Week 24
Secondary outcome [47] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [47] 0 0
Baseline, Week 48
Secondary outcome [48] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [48] 0 0
Baseline, Week 24
Secondary outcome [49] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [49] 0 0
Baseline, Week 48
Secondary outcome [50] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24
Timepoint [50] 0 0
Baseline, Week 24
Secondary outcome [51] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [51] 0 0
Baseline, Week 48
Secondary outcome [52] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [52] 0 0
Baseline, Week 24
Secondary outcome [53] 0 0
Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [53] 0 0
Baseline, Week 48
Secondary outcome [54] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [54] 0 0
Baseline, Week 24
Secondary outcome [55] 0 0
Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [55] 0 0
Baseline, Week 48
Secondary outcome [56] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24
Timepoint [56] 0 0
Baseline, Week 24
Secondary outcome [57] 0 0
Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48
Timepoint [57] 0 0
Baseline, Week 48

Eligibility
Key inclusion criteria
Key

* Cohort 1

* 12 years to < 18 years of age at baseline
* Weight greater than or equal to 35 kg (77 lbs)
* Plasma HIV-1 ribonucleic acid (RNA) levels of = 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
* Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
* No prior use of any approved or experimental anti-HIV-1 drug for any length of time
* Cohort 2

* 6 years to < 12 years of age at baseline
* Weight greater than or equal to 25 kg (55 lbs)
* Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for = 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
* Cohort 3

* Age at baseline: = 2 years old
* Weight at screening: = 14 kg (31 lbs) to < 25 kg (55 lbs)
* Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for = 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Key
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hepatitis B or hepatitis C virus infection
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
* Individuals experiencing decompensated cirrhosis
* Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
South Africa
State/province [6] 0 0
Cape Town
Country [7] 0 0
South Africa
State/province [7] 0 0
Johannesburg
Country [8] 0 0
Thailand
State/province [8] 0 0
Bangkok
Country [9] 0 0
Thailand
State/province [9] 0 0
Chon Buri
Country [10] 0 0
Thailand
State/province [10] 0 0
Khon Kaen
Country [11] 0 0
Uganda
State/province [11] 0 0
Kampala
Country [12] 0 0
Zimbabwe
State/province [12] 0 0
Belgravia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Rakhmanina N, Gaur A, Natukunda E, Chokephaibulkit... [More Details]
Journal Sharma S, Gupta S, Majeed S, Strehlau R, Hellstrom... [More Details]
Journal Natukunda E, Gaur AH, Kosalaraksa P, Batra J, Rakh... [More Details]
Journal Rakhmanina N, Natukunda E, Kosalaraksa P, Batra J,... [More Details]
Journal Gaur A, Natukunda E, Kosalarksa P, Batra J, Rakhma... [More Details]
Journal Gaur AH, Kizito H, Prasitsueubsai W, Rakhmanina N,... [More Details]
Journal Gaur A, Kizito H, Chakraborty R, Batra J, Kosalara... [More Details]
Journal Natukunda E, Liberty A, Strehlau R, Hellstrom E, H... [More Details]
Journal Natukunda E, Liberty A, Strehlau R, Hellstrom E, H... [More Details]
Journal Liberty A, Strehlau R, Rakhmanina N, Chokephaibulk... [More Details]
Journal Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, L... [More Details]
Journal Porter DP, Bennett SR, Quirk E, Miller MD, White K... [More Details]
Journal Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, L... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01854775